MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; EPIDURAL ANESTHESIA KIT

Model Number PAIN0763

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2022

Event Type  malfunction  

Event Description

Single shot epidural tray "syringe 7 ml" or "loss of resistance syringe" malfunctioned (not working) in 4 separate kits.Manufacturer response for 7ml syringe, single shot epidural tray (per site reporter).

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 13691504
• MDR Text Key: 286768847
• Report Number: 13691504
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PAIN0763
• Device Catalogue Number: PAIN0763
• Device Lot Number: 21KLB157
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/25/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female